Job Description
We are seeking a Senior Regulatory and Medical Writer to join our team at CK Group, a leading consultancy specializing in Advanced Therapies and Rare Diseases.
Responsibilities
* Support the medical writing team in regulatory affairs, clinical operations, and medical affairs across various projects.
* Prepare clinical documents, such as clinical study protocols and amendments, clinical study reports, and investigator's brochures/investigator's brochure updates.
* Develop EU and US regulatory documents.
* Manage projects, including document review processes and quality control (QC) reviews.
* Provide editorial support and formatting for documents authored by colleagues.
* Precise peer review of documents created by other team members.
* Offer guidance and training to junior medical writers and team members.
Qualifications
* A B.Sc. in a life sciences subject (a higher degree is advantageous).
* Excellent written and verbal communication skills.
* Proficient in Microsoft Office with strong Word skills.
* Experience in preparing clinical documents.
* Familiarity with EU and US regulatory documents preparation would be beneficial.
* Project management skills, including project timelines creation and client liaison.